Table 3. Long-term clinical outcome.
| Octogenarians, n = 261
446 patient-years |
Non-octogenarians, n = 483
1056 patient-years |
P-value | ||||
| Data provided as n (%) or mean ± SD. ASA: acetylsalicylic acid; NOACs: non-vitamin K dependent oral anticoagulants; TIA: transient ischemic attack. | ||||||
| Age at follow-up, yrs | 86.1 ± 3.3 | 73.2 ± 7.6 | < 0.0001 | |||
| Time from study inclusion to follow-up in years | 1.7 ± 1.3 | 2.3 ± 1.6 | < 0.0001 | |||
| Events/Patient-years | Observed rate | Events/Patient-years | Observed rate | |||
| Primary efficacy endpoint | 61/446 | 13.7 (10.8-17.12) | 80/1,056 | 7.6 (6.1-9.3) | < 0.0001 | |
| Primary safety endpoint | 30/446 | 6.7 (4.8-9.4) | 47/1,056 | 4.4 (3.4-5.9) | 0.48 | |
| Combined hazard endpoint | 82/446 | 18.4 (15.1-22.2) | 116/1,056 | 11.0 (9.2-13.0) | < 0.0001 | |
| All-cause death | 83/446 | 18.6 (15.3-22.5) | 101/1,056 | 9.6 (7.9-11.5) | < 0.0001 | |
| Cardiovascular/unexplained death | 58/446 | 13.0 (10.2-16.4) | 70/1,056 | 6.6 (5.3-8.3) | < 0.0001 | |
| Stroke and TIA (any) | 19/446 | 4.3 (2.7-6.6) | 22/1,056 | 2.1 (1.4-3.1) | 0.01 | |
| Stroke without TIA (any) | 15/446 | 3.4 (2.0-5.5) | 20/1,056 | 1.9 (1.2-2.9) | 0.049 | |
| Disabling stroke | 9/446 | 2.0 (1.1-3.8) | 12/1,056 | 1.1 (0.7-2.0) | < 0.0001 | |
| Non-disabling stroke | 7/446 | 1.6 (0.8-3.2) | 7/1,056 | 0.7 (0.3-1.4) | < 0.0001 | |
| Ischemic stroke | 15/446 | 3.3 (2.0-5.5) | 18/1,056 | 1.7 (1.1-2.7) | < 0.0001 | |
| Hemorrhagic stroke | 0/446 | 0 | 2/1,056 | 0.2 (0.1-0.7 | 0.005 | |
| TIA | 4/446 | 0.9 (0.3-2.3) | 2/1,056 | 0.2 (0.1-0.7) | 0.02 | |
| Systemic embolism | 1/446 | 0.2 (0.3-2.3) | 3/1,056 | 0.3 (0.1-0.8) | 0.35 | |
| Any bleeding | 40/446 | 9.0 (6.7-12.0) | 58/1,056 | 5.5 (4.3-7.0) | 0.020 | |
| Major bleedings | 21/446 | 4.7 (3.1-7.1) | 26/1,056 | 2.5 (1.7-3.6) | 0.025 | |
| Anti-thrombotic therapy at time of follow-up | ||||||
| Any oral anticoagulation | 25 (7.3%) | 42 (8.7%) | 0.77 | |||
| Vitamin K antagonists | 5 (1.9%) | 17 (3.5%) | 0.20 | |||
| NOACs | 18 (6.9%) | 23 (4.8%) | 0.26 | |||
| ASA | 172 (65.9%) | 310 (64.2%) | 1.0 | |||
| Platelet inhibitors other than ASA | 40 (15.3%) | 63 (13.0%) | 0.90 | |||